法规知识库 · EMA 集中审评
Caprelsa
vandetanib · EMEA/H/C/002315 · 已授权
获批上市许可
2012-02-16
欧委会决定日
2026-08-03
持有人 / 申请人
Esteve Pharmaceuticals, S.A.
终止日期字段
无
从产品到官方文件
文件记录
14
官方索引 14
EPAR / 审评
12
assessment / overview 等
产品信息
2
PI / presentations
其他
0
RMP / PIP 等
ATC：L01XE
治疗领域：Thyroid Neoplasms
药理分类：Antineoplastic and immunomodulating agents
修订号：32 · 最新影响 PI 的程序：N/0000365370
适应症（原文）：Caprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. Caprelsa is indicated in adults, children and adolescents aged 5 years and older. For patients in whom re-arranged-during-transfection(RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision.
关键日期时间轴
来自 EMA medicines JSON 日期字段；缺失字段不展示，不补推结论。
2026-08-03 · 欧委会决定
2012-02-16 · 获批上市许可
2011-11-17 · CHMP 意见通过
说明书、EPAR 与其他文件
仅展示 EMA 官方 document_url；本站不下载或镜像 PDF。
EPAR / 审评资料
- 打开官方文件 ↗
Caprelsa : EPAR - Procedural steps taken and scientific information after authorisation
procedural-steps-after · 2026-08-05
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Caprelsa : EPAR - Procedural steps taken and scientific information after authorisation (archive)
procedural-steps-after · 2024-09-23
- 打开官方文件 ↗
Caprelsa-H-C-2315-II-0043 : EPAR - Assessment Report - Variation
variation-report · 2023-03-09 · EMA/CHMP/30610/2023
- 打开官方文件 ↗
Caprelsa-H-C-2315-R-0055 : EPAR - Assessment Report - Renewal
variation-report · 2023-03-09 · EMA/CHMP/113263/2023
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Caprelsa-H-C-PSUSA-00009327-202204 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2023-02-01 · EMA/48093/2023
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Caprelsa-H-C-PSUSA-00009327-202104 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
scientific-conclusion · 2022-01-28 · EMA/49355/2022
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Caprelsa : EPAR - Risk-management-plan summary
rmp-summary · 2020-12-07
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Caprelsa-H-C-2315-II-0016 : EPAR - Assessment Report - Variation
variation-report · 2017-02-09 · EMA/CHMP/199988/2016
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Caprelsa : EPAR - Summary for the public
overview · 2017-02-09 · EMA/92285/2012
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Caprelsa-H-C-PSUSA-00009327-201504 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation
scientific-conclusion · 2016-02-29 · EMA/155536/2016
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Caprelsa : EPAR - Conditions imposed on member states for safe and effective use - Annex IV
conditions-member-states · 2012-03-02
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Caprelsa : EPAR - Public assessment report
assessment-report · 2012-03-02 · EMA/128076/2012
数据来自 EMA 官方 JSON；最终以 EMA / 欧委会文件为准。本页不自动给出安全或非安全结论。